Validation Process

Validation Process

Azad Saadalla

Azad Saadalla

Mercer Middle East

Mercer Middle East

Validation Process

Validation Process

1

( Commissioning)

( Commissioning)

Installation
qualification
( IQ)

Operational

Qualification
( OQ )

( Performance Qualification )

V

alidation

alidation

Physical
Qualification

( Through
thermocouple
testing )

Microbiological
Qualification

(Through the
placement of
biological
indicators)

Validator

Preventative
Maintenance
Schedule

Preventative
Maintenance
Schedule

Maintenance

Contract

Performance
Qualification
Report

Performance
Qualification
Report

Process
Suitability

Process
Suitability

Datalogger /
tools
&
Validation
sheets

Job Completed

Pre-validation

Maintenance

Pre-validation

Maintenance

Dry block

Datalogger
Temperature
Probes and
pressure is
calibrated

Prepare
Reference
Loads,
Incubators,
BI’s and
Bowie dick

Prepare
Reference
Loads,
Incubators,
BI’s and
Bowie dick

Performance Qualification Stages

O
N

S
I
T
E

Customer

Performance
Qualification
TESTS

Performance

Performance

Qualification

Qualification

TESTS

TESTS

Check
List

Check
List

B
E
F
O
R
E

V
A
L
I
D
A
T
I
O
N

A
F
T
E
R

Validation
Certificate

Validation
Certificate

2

3

Check
Validation
Results

Check
Validation
Results

LEAK RATE CYCLE

AIR DETECTOR PERFORMANCE TEST

TEST PACK CYCLE

Performance Qualification

Performance Qualification

TESTS

TESTS

REFERENCE LOAD (LOAD PATTERN)

2

3

Reference Load

Reference Load

PREPARING THE REFERENCE LOAD

VALIDATING THE REFERENCE LOAD

VALIDATING THE REFERENCE LOAD

AS/NZS 4187:2003

3

Samples

4

Reference Load ( Loading patterns)

Reference Load ( Loading patterns)

Samples

Samples

To prepare a
reference load; a
number of questions
will come to our
mind.

1.

What are the
setting parameters
for this load?

2.

What will be the
maximum load and
how to Load the
trolley?

3.

What type, who
many and where to
position the
Biological
indicators?

4.

Where to place the
Temperature
sensors?

5.

What is the total
time for the cycle?

END

Machine, Load Id

Load Parameters

Bio-logical Indicators

Bio-logical Positions

Probe Placement

conclusion

Samples

Instruments

4MM
Scope

Light
Handle

Large Battery
Bone Drill

(1)

Spinal
Set(2)

Load Configuration

What is the maximum load to

What is the maximum load to

be used ?

be used ?

Where is the best position for

Where is the best position for

the equipment on the load?

the equipment on the load?

How to wrap each type of

How to wrap each type of

instruments?

instruments?

Conclusions

Conclusions

̈

̈

Find out the total number of Biological

Find out the total number of Biological

indicators to be used in each load and for all

indicators to be used in each load and for all

loads.

loads.

̈

̈

How many Biological Incubators?

How many Biological Incubators?

̈

̈

How long will the tests all together takes?

How long will the tests all together takes?

̈

̈

What load and materials will be needed.

What load and materials will be needed.

(Kimgaurds,

(Kimgaurds,

steri

steri

-

-

peel, linen & instruments ) ?

peel, linen & instruments ) ?

Validation Calculator

Estimate time between loads

Total Cycle Time

114

12

4

12

4

12

4

30

10

4

2

15

5

Total No. of Strips

195

24

8

30

10

12

4

60

20

24

8

45

15

Total No. of BI's

Steri-Peels(Size: ? )

Steri-Peels(Size: ? )

Steri-Peels(Size: ? )

Steri-Peels(Size: ? )

Steri-Peels(Size: ? )

Filters

Geneses Crates

Total

* 3

Ref # 6

* 3

Ref # 5

* 3

Ref # 4

* 3

Ref # 3

* 3

Ref # 2

* 3

Ref # 1

Reference/Details

Estimate from total No. Of BI's and time between cycles how
many Biological indicators will be needed.

Important Note

: A Full Service Maintenance

should be done before validation.

Validation Calculator

Customer Name:

Southern Cross Brightside

Machine Type

:

Pre-Vacuum Sterilizer S1

Load Type

:

Light Load Ref#1

Load Parameters:
Set Temperature in sterilizing time: 134 C
Sterilizing time : 4 Minutes
Drying Time: 12 Minutes

Define the Set

temperature

for the load

within the

sterilizing

phase

Define the period

of time the load

needs to stay

within the

sterilizing phase

Define the

period of time

load needs to

stay within the

sterilizing

phase

1.

1.

-

-

Washer Sterilizer

Washer Sterilizer

̈

̈

Wash

Wash

stage :

stage :

this stage

this stage

has been

has been

programm

programm

ed either

ed either

to get to

to get to

50 C and

50 C and

ends after

ends after

5 minutes

5 minutes

or a total

or a total

of 8

of 8

minutes.

minutes.

Problem:

While
monitoring
the machine
using a
datalogger ,
the maximum
temperature
in the
washing
stage,
reached 38 at
the end of the
8 minutes.

•

•

identify the problem by the

identify the problem by the

user?

user?

•

•

1. There was no chart

1. There was no chart

recorder on that machine.

recorder on that machine.

•

•

2. No

Test was done.

2. No

Test was done.

•

•

3. This Validation was done

3. This Validation was done

on the machine after been

on the machine after been

used for 7 years .

used for 7 years .

To result is clear that we are not
sure the machine was

̈

̈

What

What

indicator type will be used?

indicator type will be used?

̈

̈

Include the Batch Number at the time of

Include the Batch Number at the time of

the validation to be documented in the

the validation to be documented in the

report ?

report ?

̈

̈

How many biological Indicators will be

How many biological Indicators will be

used?

used?

Biological Indicators

P 67 :Table 8.1 Guide

̈

̈

As indicated in AS/NZS 4187:2003

As indicated in AS/NZS 4187:2003

Biological/enzymatic indicators should be placed

Biological/enzymatic indicators should be placed

adjacent to the temperature probes.

adjacent to the temperature probes.

̈

̈

In order to validate steam penetration in oblong

In order to validate steam penetration in oblong

or square

or square

-

-

based rigid reusable sterilization

based rigid reusable sterilization

container systems, physical, chemical and bio

container systems, physical, chemical and bio

-

-

logical/enzymatic indicators should be placed in

logical/enzymatic indicators should be placed in

each corner and in the center

each corner and in the center

Bio-logical Positions

119

̈

̈

Two in the drain.

Two in the drain.

̈

̈

The rest in coldest spots, Hardest Load packs

The rest in coldest spots, Hardest Load packs

and in different positions where needed.

and in different positions where needed.

Probe Placement ( Temperature Sensors)

Reference Load ( Loading patterns)

Reference Load ( Loading patterns)

̈

̈

To Validate a Pre

To Validate a Pre

-

-

vacuum Sterilizer we need to pass special tests

vacuum Sterilizer we need to pass special tests

̈

̈

( Leak Rate Cycle

( Leak Rate Cycle

…

…

)( Test Pack

)( Test Pack

…

…

)( Air Detector Performance Test

)( Air Detector Performance Test

…

…

)

)

̈

̈

the last test which is the most important is the Load Reference

the last test which is the most important is the Load Reference

Test.

Test.

̈

̈

The Purpose for this test : The killing of all spores on the bio

The Purpose for this test : The killing of all spores on the bio

logical

logical

indicators shall evidence acceptance assurance of sterility; thr

indicators shall evidence acceptance assurance of sterility; thr

ee

ee

consecutive test runs are required for each cycle in which the

consecutive test runs are required for each cycle in which the

sterilizer values are not altered.

sterilizer values are not altered.

Reference Load ( Loading patterns)

Reference Load ( Loading patterns)

Samples

Samples

Hard Goods
4 minutes

timing

30 minutes drying

Hard Goods

Hard Goods

4 minutes

timing

4 minutes

timing

30 minutes drying

30 minutes drying

Wrapped Goods
4 minutes Timing
35 minutes drying

Wrapped Goods

Wrapped Goods

4 minutes Timing

4 minutes Timing

35 minutes drying

35 minutes drying

Validating the reference load

Validating the reference load

̈

̈

After loading the trolley, my job is to check that the load have

After loading the trolley, my job is to check that the load have

been set according to

been set according to

the reference load and indicators are in place.

the reference load and indicators are in place.

̈

̈

Place all Temperature sensors in place.

Place all Temperature sensors in place.

̈

̈

Run the cycle and monitor all parameters( Time, Temperature and

Run the cycle and monitor all parameters( Time, Temperature and

pressure ) within

pressure ) within

all stages and document all readings.

all stages and document all readings.

̈

̈

At the end of the cycle check the dryness ,all contents will be

At the end of the cycle check the dryness ,all contents will be

opened and checked, if

opened and checked, if

any contents are wet, the pack shall be deemed un sterile(28) or

any contents are wet, the pack shall be deemed un sterile(28) or

in other words any

in other words any

items that are moist at the end of the drying stage should be re

items that are moist at the end of the drying stage should be re

jected(91).

jected(91).

̈

̈

Be sure the all biological indicators are incubated.

Be sure the all biological indicators are incubated.

̈

̈

Make sure that everything has been cooled down and repacked befo

Make sure that everything has been cooled down and repacked befo

re being used

re being used

again.

again.

̈

̈

In case of failure result caused by overload, wrong packing, etc

In case of failure result caused by overload, wrong packing, etc

.. The problem should

.. The problem should

be solved until passing 3 successive repeated cycles.(119).

be solved until passing 3 successive repeated cycles.(119).

Observations

Observation

Observation

̈

̈

This is a bowl sets load, at first the end user where aiming to

This is a bowl sets load, at first the end user where aiming to

get 8 Sets on a load.

get 8 Sets on a load.

̈

̈

Each Bowl Set Contain a Big bowl,2 median bowls and four small

Each Bowl Set Contain a Big bowl,2 median bowls and four small

bowls.( all Metal ).

bowls.( all Metal ).

̈

̈

First run: a lot of water was inside the Sets.

First run: a lot of water was inside the Sets.

̈

̈

Second run: down to 6 sets, separate the big bowl from the other

Second run: down to 6 sets, separate the big bowl from the other

s, Add paper on the

s, Add paper on the

bottom edge of the Big Bowl.

bottom edge of the Big Bowl.

̈

̈

Third Run: all passed only on of the big bowls .

Third Run: all passed only on of the big bowls .

̈

̈

From Experience I thought that the load should pass, and after c

From Experience I thought that the load should pass, and after c

oncentrating and

oncentrating and

looking for the reason I found that the Bowls failing had a very

looking for the reason I found that the Bowls failing had a very

big carve lip on the

big carve lip on the

edge that kept a lot of water.

edge that kept a lot of water.

̈

̈

Running 3 successive repeated load without using those with carv

Running 3 successive repeated load without using those with carv

e lips.

e lips.

Paper

Installation Qualification ( IQ )

Installation Qualification ( IQ )

̈

̈

IQ shall show that the sterilizer and the

IQ shall show that the sterilizer and the

area in which it is installed comply with

area in which it is installed comply with

the manufacturer

the manufacturer

’

’

s specifications.

s specifications.

Operational Qualification ( OQ )

Operational Qualification ( OQ )

̈

̈

OQ shall prove that the installed

OQ shall prove that the installed

equipment operates within the set limits

equipment operates within the set limits

when used in accordance with the

when used in accordance with the

operational procedures.

operational procedures.

Thank you for your time

Thank you for your time